Minimally invasive surgical techniques have emerged as an important trend within the field of surgery. Minimally invasive surgery differs from standard open surgery in that surgical procedures are performed through small incisions in the body under the guidance of endoscopy, fluoroscopy, ultrasound or other remote imaging techniques. Minimally invasive surgical techniques reduce the morbidity of surgical procedures, accelerate patient recovery and, in many cases, also reduce the overall cost of surgery, especially by shortening the recovery period during which patients must stay in the hospital. Examples of minimally invasive surgery include laparoscopic, endoscopic and orthoscopic surgeries.
In recent years, there has been significant advancement of minimally invasive surgical techniques in the area of cardiac surgery. Certain cardiac surgery procedures that previously were only possible through open chest surgery have already been converted to minimally invasive surgical techniques. For example, catheter techniques have been developed for occlusion of patent material septal defects and for valvuloplasty of stenotic aortic or mitral valves. Instruments and techniques have also been developed for endoscopic approaches to the heart, allowing more complex cardiac surgical procedures, for example, the replacement of a stenotic or insufficient mitral valve, to be performed through minimally invasive surgical techniques.
A trocar or introducer is inserted through the incision and medical instruments are introduced into the abdominal cavity therethrough. The surgeon performs procedures inside the cavity by manipulating the medical instruments from outside the patient while viewing the manipulations using a closed circuit monitor connected to an imaging device called a laparoscope that is inserted into the cavity. By using such equipment and procedures, laparoscopic surgery generally results in less trauma to the patient and, consequently, a more rapid recovery than with conventional open surgery. Similar advantages apply to other forms of minimally invasive surgery.
One of the great challenges facing minimally invasive surgery is safe management of access sites after removal of the surgical instrument. In the case of percutaneous catheters, manual compression of the site is the traditional method for closure of the femoral artery, but is associated with a complication rate of up to 5%, marked discomfort and immobility for patients, and prolonged hospitalization. However, new vascular closure devices (VCDs) have been approved by the FDA and have replaced manual compression. These VCDs are associated with decreased length of stay and increased comfort for the patient.
There remains a needed for closure devices which may be used with minimally invasive surgical procedures but which are also simple, reliable and economically feasible.